NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

NORETHINDRONE ACETATE (UNII: 9S44LIC7OJ) (NORETHINDRONE - UNII:T18F433X4S), ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U)

Available from:

Glenmark Pharmaceuticals Inc., USA

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules are indicated for use by females of reproductive age to prevent pregnancy [see Clinical Studies (14)] . The efficacy of norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules in women with a body mass index (BMI) of more than 35 kg/m2 has not been evaluated. Norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules are contraindicated in females who are known to have or develop the following conditions: Risk Summary Risk Summary Contraceptive hormones and/or metabolites are present in human milk. COCs can reduce milk production in breastfeeding females. This reduction can occur at any time but is less likely to occur once breastfeeding is well-established. When possible, advise the nursing female to use other methods of contraception until she discontinues breastfeeding [see Dosage and Administration ( 2.2)] . The developmental and health benefits of breastfeeding should be

Product summary:

Norethindrone Acetate and Ethinyl Estradiol Capsules and Ferrous Fumarate Capsules are available in blisters (dispensers) containing 28 soft gelatin capsules: Each blister contains 28 capsules in the following order: Each blister is packed in a carton (NDC 68462-849-84). Cartons of 3 blisters packed individually in 3 cartons are provided for dispensing (NDC 68462-849-29). 3 cartons - each carton contains 1 blister (28): NDC 68462-849-84. Store at 25ºC (77ºF); excursions permitted to 15°C to 30ºC (59°F to 86ºF) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS
FUMARATE- NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS
FUMARATE
GLENMARK PHARMACEUTICALS INC., USA
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NORETHINDRONE
ACETATE AND ETHINYL ESTRADIOL CAPSULES AND FERROUS FUMARATE CAPSULES
SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR NORETHINDRONE
ACETATE AND
ETHINYL ESTRADIOL CAPSULES AND FERROUS FUMARATE CAPSULES.
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL CAPSULES AND FERROUS
FUMARATE
CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 1968
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
•
•
INDICATIONS AND USAGE
•
•
DOSAGE AND ADMINISTRATION
•
•
•
DOSAGE FORMS AND STRENGTHS
Norethindrone Acetate and Ethinyl Estradiol Capsules and Ferrous
Fumarate Capsules consists of 28 soft
gelatin capsules in the following order (3): (3)
•
•
CONTRAINDICATIONS
•
•
•
•
•
WARNINGS AND PRECAUTIONS
•
WOMEN OVER 35 YEARS OLD WHO SMOKE SHOULD NOT USE NORETHINDRONE ACETATE
AND
ETHINYL ESTRADIOL CAPSULES AND FERROUS FUMARATE CAPSULES. (4)
CIGARETTE SMOKING INCREASES THE RISK OF SERIOUS CARDIOVASCULAR EVENTS
FROM
COMBINATION ORAL CONTRACEPTIVE (COC) USE. (4)
Norethindrone acetate and ethinyl estradiol capsules and ferrous
fumarate capsules are a
combination of norethindrone acetate, a progestin, and ethinyl
estradiol, an estrogen, indicated for
use by females of reproductive potential to prevent pregnancy (1)
The efficacy of norethindrone acetate and ethinyl estradiol capsules
and ferrous fumarate capsules in
females of reproductive potential with a body mass index (BMI) of > 35
kg/m has not been evaluated
(1, 8.8)
2
Take one capsule by mouth at the same time every day (2.1)
Take capsules in the order directed on the blister pack (2.1)
Capsules may be administered without regard to meals (2.1)
24 pink capsules (active), each containing 1 mg noreth